Back to resultsA Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
Primary Purpose
Healthy Participants
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986447
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Participants focused on measuring Pharmacokinetics, Pharmacodynamics, Healthy Participants, BMS-986447
Eligibility Criteria
Inclusion Criteria: Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive. Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations. A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2. Exclusion Criteria: Participant has any condition that confounds the ability to interpret data from the study. Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study. Any major surgery or planned surgery (except gastrointestinal [GI] surgery, as described below) within 12 weeks of study intervention administration. Note: Other protocol-defined inclusion/exclusion criteria apply.
Sites / Locations
- Anaheim Clinical Trials, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BMS-986447
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events (AEs)
Number of Participants with Serious AEs (SAEs)
Number of Participants with Clinical Laboratory Abnormalities
Number of Participants with Vital Sign Abnormalities
Number of Participants with Physical Examination Abnormalities
Number of Participants with Electrocardiogram (ECG) Abnormalities
Secondary Outcome Measures
Maximum observed plasma concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)
Apparent terminal phase half-life (T-Half)
Full Information
NCT ID
NCT05760937
First Posted
February 27, 2023
Last Updated
September 5, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05760937
Brief Title
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
Official Title
A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
August 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
Pharmacokinetics, Pharmacodynamics, Healthy Participants, BMS-986447
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMS-986447
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986447
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AEs)
Time Frame
Up to 59 days
Title
Number of Participants with Serious AEs (SAEs)
Time Frame
Up to 59 days
Title
Number of Participants with Clinical Laboratory Abnormalities
Time Frame
Up to 34 days
Title
Number of Participants with Vital Sign Abnormalities
Time Frame
Up to 35 days
Title
Number of Participants with Physical Examination Abnormalities
Time Frame
Up to 35 days
Title
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time Frame
Up to 34 days
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 72 hours postdose
Title
Time of maximum observed plasma concentration (Tmax)
Time Frame
Up to 72 hours postdose
Title
Apparent terminal phase half-life (T-Half)
Time Frame
Up to 72 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive.
Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.
Exclusion Criteria:
Participant has any condition that confounds the ability to interpret data from the study.
Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
Any major surgery or planned surgery (except gastrointestinal [GI] surgery, as described below) within 12 weeks of study intervention administration.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina Haggag, Site 0001
Phone
714-774-7777
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
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